Recruiting

Opioid Treatment

Sponsor:

Brown University

Code:

NCT04978168

Conditions

Opioid-use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Core Intervention

Peer Support Specialists (PSS)

Treatment as Usual (TAU)

Study Details

Brief summary:

Determine whether a facilitated local change team intervention improves a probation organization's client-level medication for opioid use disorder (MOUD) outcomes and implementation outcomes relative to baseline across multiple sites. Determine whether client-level outcomes are further enhanced by the introduction of Peer Support Services.

Conditions

Opioid-use Disorder

Study ID

NCT04978168

Start date

Mar 2, 2021

Status verified date

May, 2025

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Dec 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Community Provider Staff: Any front-line treatment provider at an agency participating in this study who: (a) provides support to MOUD clients, (b) has an active caseload including some individuals on probation, and (c) willing to commit to 12 months to the project.
  • Probation/Parole Staff: Any probation officer (PO) at an agency participating in this study who (a) has an active caseload, and (b) is willing to commit to 12 months to the project.
  • Individuals on Probation: (a) 18 years or older, (b) committed to probation within 90 days prior to study enrollment, (c) English speaking, (d) diagnosed with OUD, (e) have stable method of contact in community

Exclusion Criteria:

  • Individuals on Probation: Currently incarcerated or in a court-mandated inpatient treatment.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Implementation Core

During baseline Exploration, staff organizational surveys are collected. During Preparation, staff focus groups conduct needs assessment with system mapping of linkage points for screening, assessment, and referral, and the agencies/staff involved in these activities. During Implementation, sites use facilitated local change teams (LCT) provided with a core set implementation strategies to facilitate linkages between probation agencies and local community treatment providers. The LCTs identify barriers to change, approaches to overcome barriers, do goal selection using SMART (specific, measurable, achievable, relevant, timely) goals and evidence for medications, address stigma, and clarify needs/expectations/roles of probation officers and treatment providers, then choose and implement goals and strategies. Sustainability Phase: Facilitators work with LCTs for 12 months using a written action plan based on goal selection.

experimental: Randomized Trial of Peer Support Specialist Model

After Core implementation is complete, half of adult participants in probation who consent will be randomly assigned to a Peer Support Specialist (PSS) condition. PSS are assigned to adults diagnosed with OUD within 6 months of entry into probation, in addition to treatment as usual. PSS establish linkages to community providers (medical, mental health, substance use treatment); educate about recovery support services, transportation assistance, MOUD; provide experiential, non-clinical support to individuals with SUD; share skills, offer support for setting goals and navigating the recovery process); and provide referrals and support for treatment, housing, employment, drug court, and probation.

active comparator: Randomized to Treatment as Usual

After Core Implementation is complete, half of adult participants in probation who consent will be randomly assigned to continue with usual care.

Interventions

Core Intervention

Staff are provided with a core set of implementation strategies to facilitate interorganizational linkages between probation agencies and local community treatment providers.

Peer Support Specialists (PSS)

Participants randomized to PSS will meet with a PSS for 6 months. Contact scheduled is flexible and based on the participant's needs and wants, plus written guidance for PSS-participant interactions.

Treatment as Usual (TAU)

Participants randomized to TAU will receive the services that will be offered at the time the Core Implementation intervention is completed.

Primary outcome measure

  • Individual-Level Experimental (Period 2) Outcome: Engagement in MOUD [ Time Frame: 26 weeks ]
  • Program-Level Implementation Outcome: Engagement in MOUD [ Time Frame: 26 weeks ]

Central Contacts and Locations

Central contacts

Rosemarie A Martin, PhD

401-863-6656Rosemarie_Martin@brown.edu

Jennifer Duff

401-863-6667Jennifer_Duff@brown.edu

Locations

Duke University

Recruiting

Durham, North Carolina, United States, 27708

Contacts

Lauren Brinkley-Rubinstein, PhD

919-962-1136lauren.br@duke.edu

Alice Cates

alice.cates@duke.edu

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19122

Contacts

Steven Belenko, PhD

215-204-2211sbelenko@temple.edu

Doris Weiland

doris.weiland@temple.edu

Brown University

Recruiting

Providence, Rhode Island, United States, 02912

Contacts

Rosemarie A Martin, PhD

401-863-6656Rosemarie_Martin@brown.edu

Jennifer Duff

4018636667Jennifer_Duff@brown.edu

More Information

Sponsor

Brown University

Last update posted

May 13, 2025

Last verified

May, 2025

Keywords

  • Opioid Use
  • Medications for Opioid Use

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Brown University on 2025-05-13.